Japan Tobacco Gets First FDA Approval

The U.S. Food and Drug Administration’s approval Monday of a new AIDS medicine is a first for Japan Tobacco Inc.Japan Tobacco Inc. , which spent a quarter-century researching drugs without having a product of its labs cleared for the big U.S. market.

Separately, Gilead is seeking approval for elvitegravir as a standalone drug.

According to Gilead’s annual report issued in February 2012, it made $43 million in upfront and milestone payments to Japan Tobacco as Stribild progressed toward FDA approval and will also pay an undisclosed royalty rate on sales of products that contain elvitegravir. Some analysts say Stribild sales could reach $2 billion annually by 2020.

In the U.S. and Europe, pharmaceutical research is usually the province of specialized companies. Japan, by contrast, has given the world a gout drug discovered by a textile manufacturer, a cholesterol drug from a diversified fashion and electronics company, and now, a medicine for one of the world’s leading scourges from a cigarette maker. Specialists in drug discovery say few fields are so unpredictable, and that list seems to offer ample evidence.

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